Hepatic ImpairmentPhase 1NCT07856004
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
A Phase 1 study testing Tacabrutideg in people with Hepatic Impairment and Healthy Adult Participants, run by BeOne Medicines.
Trial summary
The goal of this study is to understand how the body processes tacabrutideg in adults with different levels of liver function (normal, moderate impairment, and severe impairment). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Adult Participants
- What is being tested?
- Tacabrutideg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 22 Oct 2026to 31 Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal hepatic function, including total bilirubin ≤ ULN and AST ≤ ULN
- Clinical laboratory test results and physical examination findings within normal limits or judged as not clinically significant by the investigator
- General Exclusion Criteria:
- Prior exposure to any BTK protein degraders
- Underlying medical conditions (including laboratory abnormalities) other than stable hepatic impairment
- History of severe bleeding disorder or history of unexplained spontaneous bleeding requiring blood transfusion or other medical or surgical intervention
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- Positive urine drug screen or alcohol urine/breath test/blood results at Screening or Check-in
- Exclusion Criteria for Moderate and Severe Hepatic Impairment Groups:
- Acute hepatic disease or rapidly deteriorating hepatic function
- History of liver transplantation
- Previously diagnosed hepatocellular carcinoma, or history of cholestatic liver disease or biliary sepsis within the past 2 years
Who cannot join
- Any known or suspected hepatic disease
- Clinically significant abnormalities in liver function tests at Screening
- Require ongoing use of prescription or nonprescription medications, including herbal supplements (unless the medication is not expected to interfere with the pharmacokinetics, safety, or tolerability of the study drug)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tacabrutideg in Participants With Moderate and Severe Hepatic Impairment
The goal of this study is to understand how the body processes tacabrutideg in adults with different levels of liver function (normal, moderate impairment, and severe impairment).
Read the detailed description
Tacabrutideg is a type of medicine called a BTK degrader. BTK (Bruton's tyrosine kinase) is a protein that helps cancer cells survive. Tacabrutideg is designed to attach to the BTK protein and tag it for removal, so that the body's own cellular "clean-up" system breaks it down and clears it away. When more BTK is removed from the body, it interferes with the signals needed for the cancer cells to multiply and survive and may also reduce the chance of the cancer becoming resistant to treatment.
The purpose of this study is to look at the safety and blood levels of tacabrutideg in adults with liver problems. Results from this study will help researchers understand if dose changes are needed for adults with liver problems.
Participants will take one dose of tacabrutideg by mouth with food and remain in the clinic for about 20 days of monitoring. This study is an open-label study, meaning that both participants and study doctors will know what study drug/treatment is given.
This study will enroll approximately 24 adults in the United States (up to 16 participants with liver impairment and 8 participants with normal liver function).
The overall time to participate in this study is approximately 8 weeks. Participants will make regular visits to the clinic for health checks, blood tests, tacabrutideg administration and monitoring, and follow-up.
- Conditions
- Hepatic Impairment, Healthy Adult Participants
- Being tested
- Tacabrutideg
- Keywords
- tacabrutideg, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacabrutidegDrug
Also called BGB-16673
Single dose of tacabrutideg administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment will receive a single dose of tacabrutideg on Day 1. Receives: Drug: Tacabrutideg |
| Group 2: Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single dose of tacabrutideg on Day 1. Receives: Drug: Tacabrutideg |
| Group 3: Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment will receive a single dose of tacabrutideg on Day 1. Receives: Drug: Tacabrutideg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-tlast) of Tacabrutideg
Measured: Days 1-20
AUC from time 0 extrapolated to infinity (AUC0-∞) of Tacabrutideg
Measured: Days 1-20
Maximum observed plasma concentration (Cmax) of Tacabrutideg
Measured: Days 1-20
Time to reach maximum observed plasma concentration (Tmax) of Tacabrutideg
Measured: Days 1-20
Apparent terminal elimination half-life (t½) of Tacabrutideg
Measured: Days 1-20
Apparent oral clearance (CL/F) of Tacabrutideg
Measured: Days 1-20
Apparent volume of distribution (Vz/F) of Tacabrutideg
Measured: Days 1-20
Fraction unbound (Fu) of Tacabrutideg
Measured: Day 1
Secondary outcomes (4)
Number of Participants with Adverse Events (AEs)
Number of participants with AEs, including adverse events with onset or increase in severity level on or after single dose administration.
Measured: Approximately 30 days
Number of Participants with Laboratory Abnormalities
Number of participants with laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results. Clinical laboratory values will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for selected laboratory analytes.
Measured: Approximately 20 days
Number of Participants with Clinically Significant Vital Signs Measurements
Vital signs include pulse rate, body temperature, and blood pressure.
Measured: Approximately 20 days
Number of Participants with Clinically Significant Electrocardiogram (ECG) Values
Number of participants with clinically significant ECG values from a 12-lead ECG, including new or worsened clinically significant abnormalities such as prolonged QT interval or other significant arrythmia.
Measured: Approximately 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start22 Oct 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856004
- Sponsor's protocol ID
- BGB-16673-108
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.